The sample size requirement in a thorough QT/QTc study is discussed under a balanced parallel or crossover study design. First, we explore the impacts of various factors on the study power, including the mean effect p...
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The sample size requirement in a thorough QT/QTc study is discussed under a balanced parallel or crossover study design. First, we explore the impacts of various factors on the study power, including the mean effect profile across time and correlation among time points. Then we estimate the variability parameters needed based on multiple historical studies. Different baseline usage is illustrated to have a significant impact on the analysis variability in the parallel studies. Finally, the sample size calculations and recommendations are given for demonstrating a “negative” drug effect and the study assay sensitivity, respectively. [ABSTRACT FROM AUTHOR]
Research in oncology has changed the focus from histological properties of tumors in a specific organ to a specific genomic aberration potentially shared by multiple cancer types. This motivates the basket trial, whic...
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The objective of the present study was to determine whether vitamin D intake is associated with CVD mortality in a general population sample. The association between vitamin D intake and CVD mortality (ICD-9 code 4104...
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The primary objective of phase I oncology studies is to establish the safety profile of a new treatment and determine the maximum tolerated dose (MTD). This is motivated by the development of cytotoxic agents based on...
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Cardiovascular event trials can be designed to allow adaptation based on interim results. In this article, we first discuss a strategy either to accept noninferiority at an interim analysis or to continue the study to...
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In this article,we introduce a flexible model-free approach to sufficient dimension reduction analysis using the expectation of conditional difference *** any strict conditions,such as linearity condition or constant ...
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In this article,we introduce a flexible model-free approach to sufficient dimension reduction analysis using the expectation of conditional difference *** any strict conditions,such as linearity condition or constant covariance condition,the method estimates the central subspace exhaustively and efficiently under linear or nonlinear relationships between response and *** method is especially meaningful when the response is *** also studiedthe√n-consistency and asymptotic normality of the *** efficacy of our method is demonstrated through both simulations and a real data analysis.
For the generalized biased coin class of randomization procedures, Smythe (1988) proved asymptotic normality of the conditional linear rank test. Clinical trialists often undertake interim analysis to determine whethe...
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For the generalized biased coin class of randomization procedures, Smythe (1988) proved asymptotic normality of the conditional linear rank test. Clinical trialists often undertake interim analysis to determine whether to stop the trial early for a substantial treatment effect. In this article, we will set up one interim analysis using a conditional randomization test. The joint asymptotic distribution of the interim test statistic and the final test statistic will be explored. We also define the concept of conditional information under a randomization model. [ABSTRACT FROM AUTHOR]
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